The $34-Million Spine Surgeon

by John Fauber John Fauber,Reporter, Milwaukee Journal Sentinel/MedPage Today
October 25, 2012

Financial ties between University of Wisconsin orthopedic surgeon Thomas Zdeblick, MD, and Medtronic date to 1996 and include more than $34 million in consulting and royalty payments, according to documents from a U.S. Senate investigation.

The payments to Zdeblick were the most for any individual among the $210 million paid over 14 years by Medtronic to a group of surgeons who wrote favorable medical journal articles about the company's spine surgery product, Infuse, records to be released Thursday show.

Documents from the investigation by the U.S. Senate Committee on Finance tallied payments from 1996 to 2010. Zdeblick got another $1.5 million in 2011 and 2012, according to Medtronic's web site.

Payments to individual doctors ranged from about $3 million to the $34 million paid to Zdeblick. A Kentucky corporate entity of which two of the doctors are officers got $64.8 million between 1996 and 2010.

Investigators also found that two papers Zdeblick co-authored were among 11 in which Medtronic employees, including those in the company's marketing department, were secretly involved in drafting and editing, a practice known as ghostwriting.

Both papers were published in the Journal of Spinal Disorders & Techniques where Zdeblick has served as editor-in-chief since 2002. That role was the subject of a 2009 Journal Sentinel/MedPage Todayinvestigation that found the journal frequently published favorable articles about Medtronic products under Zdeblick's watch. The story noted that Zdeblick's financial relationship with Medtronic was not disclosed by the journal.

Both of the papers cited in the Senate investigation also have been the subject of Journal Sentinel/MedPage Today investigations, which found the papers failed to link Infuse to a complication that can cause sterility in men, though the evidence from a clinical trial showed it was a concern.

Neither of the papers disclosed that Zdeblick and his co-authors had received millions of dollars in payments from Medtronic.

Among the 5,000 documents turned over by Medtronic to Senate investigators was a 2001 PowerPoint presentation by Zdeblick that indicates he knew the sterility complication rates in a clinical trial of Infuse were higher in men who got the product than those in the control group.

Zdeblick's 2001 presentation was made to a group of other doctors involved in the Infuse clinical trial.

In the presentation, he reported that the sterility complication rate was 1.5% among men in the control group, compared with 10.3% of men who got Infuse using a laparoscopic surgical technique and 6.3% who got Infuse in an open surgical technique.

In the Power Point presentation, Zdeblick noted the 10.3% rate was "statistically different" than the control group rate.

In an email last year, he was asked by the newspaper whether he had made a mistake by not telling doctors who had read his papers about the complication.

"Wrong!" he replied. "In my experience there is no direct link between Infuse and (the complication)."

A emailed statement from Robert Golden, dean of the UW medical school, said Zdeblick has no knowledge of any ghostwriting by Medtronic employees on any of the papers.

Golden also said Zdeblick keeps copies of all his Power Point presentations and he no presentation with the data cited in the Senate report.

"Nor does he have any information or recollection of presenting such data to any group," he said.

"If any evidence were to emerge suggesting that important data were omitted or misused, the university would look carefully at such evidence because scientific integrity is of the utmost importance," he said. "We have no data to suggest any impropriety."

Golden added that three studies in the last year have consistently reported no scientifically proven link between Infuse and the complication.

Golden stressed that UW has not received the Senate report and it has no direct knowledge of what it says.

According to Golden, Zdeblick receives no compensation for Infuse or any other Medtronic device implanted in UW patients.

Eugene Carragee, MD, a Stanford University surgeon, questioned why the rates of the male sterility complication in Zdeblick's presentation did not get reported in medical journal articles he co-authored.

He said it was apparent that data were available at the time they were written.

"When he writes the papers it all goes out the window," Carragee said. "It looks terrible."

Carragee also served as editor of the Spine Journal, which last year published an unprecedented issue that repudiated 13 papers written over nearly a decade about Infuse by doctors with financial ties to Medtronic.

Last year, Stanford researchers published a study of their own patients that a found strong evidence that Infuse caused the sterility complication.

This story was reported as a joint project of the Journal Sentinel and MedPage Today.

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